A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

CTTQ

Status and phase: Enrolling; Phase 2

Conditions: B-cell Lymphoma

Treatments: Drug: TQB3702 tablets+Chemotherapy regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT06566586

TQB3702-II-02

Details and patient eligibility

About

To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;

• Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Eastern cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3 months;

• Histologically confirmed B-cell lymphomas of the following types that meet the 2022 World Health Organization (WHO) diagnostic criteria:

  1. Relapsed/refractory indolent B-cell lymphoma
  2. Diffuse large B cell lymphoma（DLBCL）

• Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at least one previous line of systemic standard therapy

• Have at least one measurable lesion.

• The main organs function well.

• Female subjects of reproductive age should agree to use contraception (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.

Exclusion criteria

• Have had or are currently suffering from other malignant tumors within 3 years prior to the first medication.
• Known or suspected central nervous system (CNS) aggression.
• Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 3 months before the first treatment;
• Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to ≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1 due to any previous treatment, excluding hair loss and fatigue;
• Have multiple factors that affect oral drug absorption (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
• Received major surgical treatment or significant traumatic injury within 28 days before the start of study treatment;
• Hyperkinetic/venous thrombosis events occurred within 6 months before the first medication;
• Have a history of psychotropic drug abuse and can not quit or have mental disorders;
• Subjects with any severe and/or uncontrolled disease;
• Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks before the first dose, or planned to receive live vaccine or mRNA vaccine during the study;
• Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication;
• Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

TQB3702 tablets+Chemotherapy regimen

Experimental group

Description:

TQB3702 tablets 200mg, every 4 weeks for a treatment cycle. Chemotherapy regimen：Every 3 or 4 weeks is a treatment cycle, with 6 or 12 cycles of combination therapy

Treatment:

Drug: TQB3702 tablets+Chemotherapy regimen